BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ODYSSEY

    MDR report key: 1915430 · Received November 4, 2010

    Report

    Report Number
    2032139-2010-00005
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 4, 2010
    Manufacturer
    PERMEDICS, INC.
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN URGENT MEDICAL DEVICE CORRECTION LETTER WILL BE DISTRIBUTED TO ALL AFFECTED CUSTOMERS BY (B)(6), 2010, WITH A DESCRIPTION OF THE ANOMALY AND USER CORRECTIVE ACTION STEPS. THE LETTER WILL ALSO BE DISTRIBUTED TO THE PERMEDICS SALES ORGANIZATIONS, INFORMING THEM OF THE ISSUE. A MANDATORY UPGRADE WILL BE PROVIDED BY (B)(6), 2011 AT NO CHARGE. IN THE MEANTIME, THE FOLLOWING RECOMMENDATIONS ARE PROVIDED: IF, PRIOR TO THE SOFTWARE CORRECTION, THE USER CHANGED THE PT'S TREATMENT START DATE ON ANY FULLY-COMPUTED IMRT PLAN, IMAT PLAN OR PLAN CONTAINING A "REGION DVH" PRESCRIPTION, THE USER SHOULD FORCE A FULL RE-COMPUTATION OF THOSE PT PLANS PRIOR TO FIXING AND EXPORTING THE PLAN. THE FOLLOWING PROCEDURE CAN BE USED TO FORCE A FULL RE-COMPUTATION OF THE PLAN: OPEN THE PT'S PLAN WORKSHEET. CHANGE THE ALGORITHM TYPE OF THE PLAN. CHANGE THE ALGORITHM TYPE BACK TO ITS ORIGINAL VALUE. CLOSE THE PLAN WORKSHEET. RE-COMPUTE THE PLAN.

    Description of Event or Problem · 1

    AN ANOMALY WAS FOUND IN THE ODYSSEY SOFTWARE: IF THE TREATMENT START DATE IS CHANGED FOR A PT'S FULLY COMPUTED IMRT PLAN, IMAT PLAN OR A PLAN CONTAINING A "REGION DVH" PRESCRIPTION, THEN ODYSSEY AUTOMATICALLY RE-COMPUTES THE TREATMENT SCHEDULE. HOWEVER, THIS AUTOMATIC RE-COMPUTATION ALSO CHANGES THE MONITOR UNIT VALUES IN THE SCHEDULE, SO THEY ARE NO LONGER CORRECT. IN THESE CASES, IT IS NECESSARY TO MANUALLY PERFORM A FULL RE-COMPUTATION OF THE PLAN TO CALCULATE THE CORRECT MONITOR UNIT VALUES FOR THE TREATMENT SCHEDULE; HOWEVER, ODYSSEY DOES NOT PROVIDE INDICATION TO THE USER OF THIS ANOMALY, AND ALLOWS EXPORT OF THE PLAN WITH THESE INCORRECT MONITOR UNIT VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ODYSSEY RADIATION TREATMENT PLANNING SYSTEM MUJ PERMEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1